Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT02228018
Status:
WITHDRAWN
Last Update Posted:
2016-02-03
First Post:
2014-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Comparison of Electronic Auscultation Coupled With CALSA and FRI; Repeatability of FRI Biomarkers
Sponsor:
FLUIDDA nv
Organization:
Study Overview
Official Title:
The Comparison of Electronic Auscultation Coupled With Computer Aided Lung Sound Analysis (CALSA) and Functional Respiratory Imaging (FRI) and Repeatability of FRI Biomarkers in Healthy Subjects and Asthma Patients
Status:
WITHDRAWN
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Other strategies followed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
CALSA will be compared with FRI and the repeatability of the FRI parameters will be tested in a group of healthy volunteers and asthma patients.
Detailed Description:
his is a study with no investigational product. CALSA will be compared with FRI and the repeatability of the FRI parameters will be tested in a group of healthy volunteers and asthma patients.
Electronic auscultation of respiratory sounds will be performed, lung function tests (at maximal dilatation) will be executed and computed tomography (CT) scans of the thorax will be taken. The scans will be taken at two different breathing levels, more specifically at total lung capacity (TLC) and functional residual capacity (FRC) level. The scans will be taken while the patient/ volunteer lies down on the movable table of the CT-scan. After the scan is taken it will be asked to the patient/ volunteer to sit upright on the scanning table and to lie down again. When the patient/ volunteer lies down a second CT-scan (TLC and FRC) will be taken.
The objective of this study is to compare CALSA with FRI and to assess the repeatability of FRI biomarkers
Electronic auscultation of respiratory sounds will be performed, lung function tests (at maximal dilatation) will be executed and computed tomography (CT) scans of the thorax will be taken. The scans will be taken at two different breathing levels, more specifically at total lung capacity (TLC) and functional residual capacity (FRC) level. The scans will be taken while the patient/ volunteer lies down on the movable table of the CT-scan. After the scan is taken it will be asked to the patient/ volunteer to sit upright on the scanning table and to lie down again. When the patient/ volunteer lies down a second CT-scan (TLC and FRC) will be taken.
The objective of this study is to compare CALSA with FRI and to assess the repeatability of FRI biomarkers
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: